Debio 4228 for Prostate Cancer

Recruiting at 32 trial locations

Overseen By Debiopharm International S.A

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Debiopharm International SA

Must be taking: Androgen deprivation

Must not be taking: Exogenous testosterone

Disqualifiers: Abnormal cardiovascular, Diabetes, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Debio 4228 to evaluate its behavior in the body and its effects on people with prostate cancer. The trial includes different groups receiving various doses to identify the most effective and safest option. It seeks participants with prostate cancer that cannot be treated with surgery or radiation aimed at curing the disease. Those who meet this criterion and have not undergone certain treatments may be eligible to join. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy or have used exogenous testosterone recently, you may not be eligible. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Debio 4228 has undergone testing in humans. Earlier studies found it safe enough to proceed to more advanced trials, indicating that initial doses did not cause serious problems for patients.

Researchers are studying the treatment at various doses to understand its effects on the body and prostate cancer. As it is in the middle stages of testing, evidence suggests it is generally well-tolerated. Participants in these studies have not reported serious side effects that would halt further research.

Overall, Debio 4228 has demonstrated sufficient safety in humans to continue advancing in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Debio 4228 for prostate cancer because it offers a novel approach compared to current treatments like hormone therapy, surgery, and radiation. Unlike conventional therapies, Debio 4228 is administered through a single or multiple intramuscular (IM) injections, potentially simplifying the treatment process and reducing the frequency of administration. This investigational drug targets specific mechanisms within cancer cells, which could lead to more effective outcomes with fewer side effects. The potential for a new delivery method and a targeted action makes Debio 4228 a promising candidate in the fight against prostate cancer.

What evidence suggests that Debio 4228 might be an effective treatment for prostate cancer?

Research has shown that Debio 4228 is under study as a treatment for prostate cancer in this trial. Participants in different trial arms will receive varying doses of Debio 4228. This treatment is a long-lasting version of a medication that blocks certain hormones linked to prostate cancer growth. Early results suggest Debio 4228 might require fewer injections while maintaining effectiveness and safety comparable to other similar treatments. This could offer a more convenient option for patients. Initial data from other treatments in the same category have shown promising results in managing prostate cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men with advanced or metastatic prostate cancer who are candidates for ongoing hormone therapy. They should have a life expectancy of at least 6 months, be relatively active (ECOG status 0-2), and have normal organ function. Specific medical criteria must also be met.

Inclusion Criteria

Life expectancy of at least 6 months

My prostate cancer is advanced and has spread beyond the prostate.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I need hormone therapy for my cancer.

I have not had major surgery in the last 4 weeks.

I have had surgery to remove both testicles, adrenal glands, or pituitary gland.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular (IM) administration of Debio 4228 on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person) at 12 weeks

Extension

Participants in Cohort 3 may receive a maintenance dose 12 weeks after the initial dose

12 weeks

1 visit (in-person) for maintenance dose

What Are the Treatments Tested in This Trial?

Interventions

• Debio 4228

Trial Overview The study is testing Debio 4228 to understand how it's processed in the body (pharmacokinetics) and its effects on the body's biological processes (pharmacodynamics) in patients with advanced prostate cancer.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

If any alternative dose is deemed necessary based on preliminary data, participants may be enrolled in Cohort 3 to receive Debio 4228 loading dose IM, on Day 1 followed by a maintenance dose IM, 12 weeks after receiving the loading dose (Day 85).

Group II: Cohort 2: Debio 4228 Dose Level 2 Experimental Treatment 1 Intervention

Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.

Group III: Cohort 1: Debio 4228 Dose Level 1 Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1. Enrolment for cohort 1 was discontinued as per protocol amendment v5.0

Who Is Running the Clinical Trial?

Debiopharm International SA

Lead Sponsor

Trials

53

Recruited

7,300+

Published Research Related to This Trial

Abiraterone acetate has been shown to improve overall survival in patients with castration-resistant prostate cancer (CRPC) who have previously been treated with docetaxel, highlighting that CRPC remains hormone-driven even in advanced stages.

There is a need for better molecular characterization of prostate cancer to identify different disease subsets, which could lead to more effective and personalized treatment strategies, including the development of predictive biomarkers for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting continued androgen receptor signaling in prostate cancer. Massard, C., Fizazi, K.[2015]

In a study of 879 patients with metastatic prostate cancer, BRCA2, ATM, and CDK12 were identified as the most frequently disrupted DNA damage repair genes, found in 15% of cases, indicating potential therapeutic vulnerabilities.

The presence of BRCA2 and CDK12 mutations was linked to poorer clinical outcomes, while the stability of these mutations in both plasma cell-free DNA and archival tissues suggests that ctDNA could be a valuable diagnostic tool for monitoring disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRCA2, ATM, and CDK12 Defects Differentially Shape Prostate Tumor Driver Genomics and Clinical Aggression. Warner, E., Herberts, C., Fu, S., et al.[2022]

In a study of 75 patients with metastatic castration-resistant prostate cancer (mCRPC), enzalutamide showed a significantly higher PSA response rate (70.3%) compared to abiraterone (37.8%), indicating better efficacy in reducing prostate-specific antigen levels.

Patients treated with enzalutamide also experienced longer progression-free survival (7 months) and overall survival (30 months) compared to those on abiraterone (5 months and 13 months, respectively), suggesting that enzalutamide may be a more effective treatment option in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Data on Outcomes in Metastatic Castrate-Resistant Prostate Cancer Patients Treated With Abiraterone or Enzalutamide: A Regional Experience. Raju, R., Sahu, A., Klevansky, M., et al.[2023]

The ARNEO trial is a phase II study involving at least 84 patients with intermediate to high-risk prostate cancer, aiming to evaluate the effectiveness of combining apalutamide with degarelix compared to degarelix alone in reducing minimal residual disease after surgery.

This study will also explore the molecular effects of the treatment on tumors and assess various clinical outcomes, including PSA levels, testosterone levels, and quality of life, providing comprehensive insights into the safety and efficacy of this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial. Tosco, L., Laenen, A., Gevaert, T., et al.[2018]

In a study of 36 patients with locally advanced prostate cancer and germline DNA damage repair gene defects, the combination of docetaxel and cisplatin chemotherapy showed a significant improvement in biochemical progression-free survival compared to docetaxel alone, with a median bPFS not reached in the cisplatin group versus 7.76 months in the docetaxel group.

The docetaxel plus cisplatin group also demonstrated a higher rate of tumor down-staging (78.57%) compared to the docetaxel group (40.9%), indicating enhanced efficacy, while maintaining a tolerable safety profile with only one case of severe liver insufficiency due to viral hepatitis A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of neoadjuvant docetaxel + cisplatin chemo-hormonal therapy versus docetaxel chemo-hormonal therapy in patients with locally advanced prostate cancer with germline DNA damage repair gene alterations. Chi, C., Liu, J., Fan, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06395753

A Dose Finding Study of Debio 4228 in Participants With ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

2. withpower.com withpower.com/trial/phase-2-prostate-cancer-5-2024-29242

Debio 4228 for Prostate Cancer Patients treated with enzalutamide also experienced longer progression-free survival (7 months) and overall survival (30 months) compared to those on ...

3. patients.debiopharm.com patients.debiopharm.com/prostate-cancer/

Prostate Cancer - Debiopharm - Patients Therefore, patients with prostate cancer need fewer injections, while Debio 4228 is expected to work just as well and be just as safe as the 4-week formulation.

4. nycancer.com nycancer.com/trials/Debio_4228-201

Debio 4228-201: Study of Extended Release GnRH in ... A Phase 2, randomized, open-Label, dose-finding study of Debio 4228, an extended-release formulation of gonadotropin-releasing hormone antagonist.

5. ctv.veeva.com ctv.veeva.com/study/a-dose-finding-study-of-debio-4228-in-participants-with-locally-advanced-metastatic-prostate-cancer

A Dose Finding Study of Debio 4228 in Participants With ... The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

6. clinicaltrials.eu clinicaltrials.eu/trial/study-of-debio-4228-for-patients-with-advanced-or-metastatic-prostate-cancer/

Study of Debio 4228 for Patients with Advanced or ... This medication works by blocking certain hormones that can promote the growth of prostate cancer cells. The purpose of the study is to explore ...

7. trialx.com trialx.com/clinical-trials/listings/292098/a-dose-finding-study-of-debio-4228-in-participants-with-advanced-prostate-cancer/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

A Dose Finding Study of Debio 4228 in Participants With ... Overview. The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.